Kornimate/medical-research-clean huggingface dataset:
diastolic dysfunction in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus Type 2 (T2DM); Left Ventricular Diastolic Dysfunction

Summary: examination of the effect of linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography. furthermore the effect on serum levels of nt-pro bnp as a biomarker of heart failure will be investigated.

treatment: the patients will receive linagliptin 5 mg qd or placebo for a period of 6 months. the echocardiography and 24h rr measurement will be performed at baseline and 6 months after initiation of the therapy. the blood chemistry (glucose, hba1c, bnp) will be evaluated at baseline as well as 3 and 6 months after initiation of the therapy.

Eligibility criteria:
inclusion criteria: 1. diabetes mellitus type 2 2. age \> 50 years 3. hba1c \> 7% 4. left ventricular diastolic dysfunction determined by echocardiography as average e/é ≥13 or average e/é≥8 and la volume ≥34ml/m2 5. stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist). 6. indication to increase anti-diabetic medication as judged by the investigator 7. written informed consent prior to study participation exclusion criteria: 1. diabetes mellitus type 1 2. echocardiography: * decreased left ventricular systolic function, ejection fraction (ef) \<45% * regional wall motion abnormalities * hypertrophic cardiomyopathy (septum \>15mm) * severe valvular dysfunction 3. uncontrolled hypertension 4. atrial fibrillation 5. obstructive sleep apnea syndrome 6. use of dpp-4 inhibitor (dipeptidyl-peptidase iv inhibitor), glp 1 agonists, thiazolindinedione 7. kidney disease ckd 4 and more (gfr \< 30 ml/min/1.73) 8. liver disease (alt or ast \> 3 times the upper limit of norm) or known liver cirrhosis 9. active malignant disease 10. hba1c \> 8.5% 11. recent (\<3 months) clinically significant coronary or cerebral vascular event 12. pregnant females as determined by positive \[serum or urine\] hcg test at screening or prior to dosing. participants of child-bearing age should use adequate contraception as defined in the study protocol. 13. lactating females 14. the subject has a history of any other illness, which, in the opinion of the investigator, might pose an unacceptable risk by administering study medication. 15. the subject received an investigational drug within 30 days prior to inclusion into this study 16. the subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study 17. the subject is unwilling or unable to follow the procedures outlined in the protocol 18. the subject is mentally or legally incapacitated

Keywords: t2dm diastolic dysfunction
the effects of remimazolam on the incidence of severe hypoxia during sedated hysteroscopy for assisted reproduction in overweight or obese patients

Conditions: Hypoxia; Hysteroscopy; Overweight or Obesity

Summary: hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and it is more likely to occur in overweight or obese patients. in sedated gastroscopy, the incidence of hypoxia with remimazolam is lower than that with propofol. the present study is a single-center, randomized, single-blind, controlled clinical trial. overweight or obese patients undergoing sedated hysteroscopy for diagnosis and treatment, with asa grade i or ii, were selected as subjects and randomly divided into an experimental group and a control group, with 300 subjects in each group. sedation induction and maintenance are performed using remimazolam or propofol combined with remifentanil, respectively, to compare the incidence of severe hypoxia during surgery between the two groups of patients.


Eligibility criteria:
inclusion criteria: 1. age between 20 and 50 years. 2. patients undergoing sedated hysteroscopy for assisted reproduction. 3. asa classification i-ii. 4. bmi ≥ 23 kg/㎡. 5. patients who have signed an informed consent form. exclusion criteria: 1. spo2 \< 95% in patients inhaling air upon entering the room. 2. diagnosed with chronic obstructive pulmonary disease (copd) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy. 3. patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, alzheimer's disease, myasthenia gravis, etc. 4. patients with severe liver dysfunction. 5. patients with severe renal insufficiency (requiring dialysis before surgery). 6. severe heart failure (mets \< 4). 7. history of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of chinese alcohol). 8. allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products. 9. breastfeeding women. 10. patients whom investigator believe are unsuitable for participating in this trial.

Keywords: hypoxia sedated hysteroscopy remimazolam propofol
evaluation of pc 6 "neiguan" with conventional acupuncture to prevent ponv after laparoscopic cholecystectomy.

Conditions: Cholecystitis; Vomiting; Nausea

Summary: assessment of the effectiveness of pc 6 "neiguan" with conventional acupuncture for preventing ponv (postoperative nausea and vomiting) after laparoscopic surgery.

utilizing acustimulation, the effect of pc 6 "neiguan" (acupuncture point pericardium 6) has been studied in ponv . conventional acupuncture has not been tested yet in laparoscopic cholecystectomy. the incidence of postoperative vomiting during the first 24 hours is the main outcome. secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with ponv management.

Eligibility criteria:
inclusion criteria: * female and male patients * \> 18 y * general anesthesia * undergoing laparoscopic surgery * patient with american society of anesthesiologists physical status i-ii * written informed consent exclusion criteria: * pregnant women and breastfeeding * patient with cardiac disease * surgery more than 2 h * no bowel surgery * signs of skin infection at or near the purposed site of the acupuncture point * patient with american society of anesthesiologists physical status iiii-iv

Keywords: laparoscopic acupuncture
transcutaneous electrical acupoint stimulation(teas) for hepatic and renal dysfunction after pneumoperitoneum

Conditions: Hepatic Dysfunction Transient; Renal Function Disorder

Summary: the purpose of this study is to compare the effect of teas pretreatment and treatment on hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing laparoscopic surgeries.

patients were randomly assigned to three groups, control group and two intervention groups, receiving teas before and after general anesthesia induction respectively. teas was given through electrodes attached to acupoints. the time for teas was 30min. venous blood samples were collected before and 20min after pneumoperitoneum. hepatic and renal function index including ast, alt, alp, bun, cr were measured.

Eligibility criteria:
inclusion criteria: * age\>18yrs,\<60yrs； * asa 1-2； * scheduled for laparoscopic surgery under general anesthesia； * informed consented exclusion criteria: * patients with hepatic or renal dysfunction； * patients with severe hypertension or cardiac dysfunction； * patients with severe pulmonary disease； * patients with hemoglobin\<100g/l

Keywords: hepatic dysfunction renal dysfunction pneumoperitoneum transcutaneous electric stimulation
compression anastomosis for low anterior resection in previously radiated patients using the car™ 27

Conditions: Colorectal Cancer

Summary: the purpose of this study is: evaluation of the safety and effectiveness of the compression anastomosis ring (car™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old. * patient is scheduled for a non-emergency tme and low anterior resection (\< 10cm from the anal verge). * patient has been radiated to the pelvic area 6-8 weeks prior to the study. * subject signs and dates a written informed consent form (icf) and indicates an understanding of the study procedures. exclusion criteria: * patient has known allergy to nickel. * patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease. * patients are participating in another clinical trial which may affect this study's outcomes. * patient has been taking regular steroid medication. * patient has contraindications to general anesthesia. * patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Keywords: compression anastomosis colorectal cancer low anterior resection radiated to the pelvic area radiotherapy
registration trial of the intracranial visualized stent for the wide-necked intracranial aneurysms

Conditions: Brain Diseases; Aneurysm; Intracranial Aneurysm; Cardiovascular Diseases

Summary: a registration trial of the intracranial visualized stent in the treatment of wide-necked intracranial aneurysms


Eligibility criteria:
inclusion criteria: * at the time of signing the informed consent form(icf), the applicant shall be male or non-pregnant female, aged 18 to 80 years; * target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio \<2) by dsa/cta/mra； * the diameter of the parent vessel should be 2.0 to 4.5mm; * the target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation; * subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily. exclusion criteria: * subject whose mrs score was greater or equal to 3 during the clinical evaluation before enrollment; * subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery; * subject with multiple aneurysms that cannot be treated by single stent; * subject with aneurysm ruptured within 30 days; * subject who is not suitable for anesthesia or endovascular surgery; * subject with significant stenosis of the parent arterty(\>50%) * subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the icf or would underwent major sugical procedure 60 days after signing the icf; * subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device; * subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc; * subject who is contraindicated with stent-assisted coiling: subject with allergy to required anti-platelet and/or heparin medications required for treatment; subject with allergy to radiographic contrast; subject with allergy to nitinol, platinum-tungsten, platinum-iridium alloy. * women who is pregnant or now breastfeeding; * subject with a life expectancy less than 12 months.
efficacy and safety of "vs002a" with the standard who-ors in non-cholera acute watery diarrhea in infants and young children

Conditions: Diarrhea, Infantile

Summary: randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population


Eligibility criteria:
inclusion criteria: 1. age: 6 months - 36 months, 2. duration of diarrhea ≤48 hours, 3. some dehydration (judged clinically according to the "dhaka method"), 4. written informed consent by either parent/guardian. exclusion criteria: 1. severe malnutrition (weight-for-length wlz/whz/waz \<-3 or presence of nutritional edema) 2. patients with diarrhea due to cholera. 3. systemic illness (e.g. pneumonia, tuberculosis, enteric fever, meningitis etc.) 4. bloody diarrhea 5. any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, down's syndrome etc.) 6. requirement of additional intravenous fluids after being provided with an iv for 4 hours on admission if severely dehydrated 7. has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.
arsucam® (artesunate + amiodaquine) efficacy and tolerance

Conditions: Malaria

Summary: primary objective: to demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on day 14, of administration of arsucam® as a single daily intake versus two daily intakes. secondary objective: to compare the clinical safety of the two treatment regimens.


Eligibility criteria:
inclusion criteria: * weighing ≥ 10 kg * residing in the area covered by the investigating centre throughout the entire follow-up period * axillary temperature ≥ 37.5 degrees celsius or history of fever within the previous 24 hours * plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre exclusion criteria: * presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic blood pressure \< 70 mmhg in adults or \< 50 in children, spontaneous bleeding, inability to sit or stand * serious concomitant disease * allergy to one of the investigational medicinal products * pregnant women or breast-feeding women. * documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.
qstat cartridge in obstetric patients

Conditions: Blood Loss Massive; Post Partum Hemorrhage

Summary: this study will assess the performance of the quantra system with the qstat cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

the quantra system is a fully integrated and automated in vitro diagnostic device which uses seer sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. the qstat cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. these patients include the tobstetric hemorrhage population. the cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. this multicenter, prospective, observational pilot study will evaluate the performance of the quantra system with the qstat cartridge as compared to standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Eligibility criteria:
inclusion criteria: * subject is greater than18 years. * subject is pregnant or at least 24 h postpartum * conventional coagulation tests and/or viscoelastic testing are ordered for concern of possible coagulopathy based on one or more clinical scenarios including hemorrhage, suspected or confirmed placental abruption, amniotic fluid embolism, or placenta accreta spectrum * subject or subject's lar is willing to provide informed consent, either prospectively or by deferred consent. exclusion criteria: * subject is younger than 18 years old. * subject or subject's lar is unwilling or unable to provide informed consent, either prospectively or by deferred consent. * subject is incarcerated at the time of the study. * subject is currently enrolled in a distinct study that might confound the results of the proposed study * subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks

Keywords: quantra viscoelastic testing coagulation
the effectiveness of varicella vaccination in children in germany

Conditions: Varicella (Chickenpox); Chickenpox Vaccines

Summary: this study is undertaken to evaluate the effectiveness of currently licensed varicella vaccines under conditions of routine use in a setting where varicella vaccine is included in the childhood immunization calendar.

observational, multicenter, population-based, matched case-control study conducted in selected pediatric practices in the munich area.

Eligibility criteria:
inclusion criteria: * male or female child at least one year of age, born on or after july 1 2003. * residence in germany * at least one previous well-child visit to the practice * written informed consent obtained from parents/guardians of the subject as per local requirements. * specific inclusion criterion for cases: * suspected primary varicella disease (i.e. chickenpox) at the time of study entry exclusion criteria: * ineligible for varicella vaccination, due to any medical contraindication. these contraindications are: * history of hypersensitivity to any of the components of the vaccines * congenital or acquired immunodeficiency * treatment with immunosuppressive therapy * hiv-infected patients, when cd4 \< 25% of total lymphocytes * previous history of chickenpox by physician record or parental report. * lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet).

Keywords: varicella case-control
a study of ly3457263 in obese participants

Conditions: Overweight; Obesity

Summary: the main purpose of this study is to evaluate the safety and tolerability of ly3457263 when administered in combination with tirzepatitide in overweight or obese participants. the study will also evaluate how much of ly3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. the study will last up to approximately 11 weeks.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation * have a stable body weight and body mass index (bmi) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²) * male or female participants not of childbearing potential exclusion criteria: * have a mean sitting systolic blood pressure (bp) higher than 160 millimeters of mercury (mmhg) or a mean sitting diastolic bp higher than 90 mmhg from 3 measurements * have an abnormal 12-lead electrocardiogram (ecg) at screening * have type 1 or type 2 diabetes mellitus
degree of benefit from low-frequency acoustic amplification using the advanced bionics acoustic earhook

Conditions: Cochlear Implant; Cochlear Hearing Loss

Summary: the primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved advanced bionics acoustic earhook. the aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in ci recipients both with and without use of the acoustic ear hook.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * implanted with an advanced bionics advanced bionics hires ultra, 90k, or cii implant, and using a naída q90 sound processor * 18 years of age or older with post-lingual hearing loss * aided open-set speech recognition scores greater than 30% correct in quiet in the ear to be tested * unaided low frequency audiometric hearing thresholds of 90 db hl or better at .125, .25, and .5 khz * participants must have a working understanding of and ability to verbalize in english as the evaluation measures are available exclusively in english * willingness to use an acoustic component with their ear-level sound processor postoperatively for the duration of the study * willingness to participate in all scheduled procedures outlined in the protocol exclusion criteria: * exclusive use of a body worn external sound processor * deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear * postoperative unaided low frequency audiometric hearing thresholds in the implanted ear exceeding 90 db hl at any frequency from 125 - 500 hz. * presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation or outcomes measures.
search for predictive factors of resistance to treatment for metastatic castration-resistant prostate cancer by studying the expression of micrornas

Conditions: Prostate Cancer; Resistance, Disease; MicroRNAs

Summary: several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in france. the oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. it is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. it shows why resistant mechanisms to treatment need to be elucidated. microrna (mir) are short rna, implicated in messenger ribonucleic acid (mrna) regulation. evidence is emerging that mir is implicated in prostate cancer response to treatment. it would be interesting to determine if a mir profile can predict treatment response to chemotherapy and/or to novel hormonal agents.

several drugs are available for metastatic castration resistant prostate cancer such as chemotherapy (docetaxel, cabazitaxel) and novel hormonal agents (abiraterone, enzalutamide), in france. the oncologist has to choose between those two type of treatment, without any biological predictor of efficacy for his patient. it is always difficult to choose knowing that 30 to 50% of patients won't benefit from the treatment chosen. it shows why resistant mechanisms to treatment need to be elucidated. microrna (mir) are short rna, implicated in messenger ribonucleic acid (mrna) regulation. evidence is emerging that mir is implicated in prostate cancer response to treatment. it would be interesting to determine if a mir profile can predict treatment response to chemotherapy and/or to novel hormonal agents.

Eligibility criteria:
inclusion criteria: * prostate adenocarcinoma * metastatic disease, proven (ct or bone scintigraphy or mri or positron emission tomography(pet)-ct or x ray) * castration resistance, proven with biology or radiologic progression * affiliated to a french social security regimen exclusion criteria: * other cancer within five years * any judiciary protection measure